Is it okay to follow a COVID-19 vaccination recommendation by a medical society or CDC, that is not within the FDA-approved labeling?

A recommendation and an FDA-approved indication are different. FDA labeling regulates the marketing of a vaccine, but not the practice of medicine. Off-label vaccination recommendations made by CDC and medical societies are not rare and typically occur when available data outstrips the pace of regulatory changes (or when it is unlikely the manufacturer will go through the expense and process of changing the label). When a major medical society or CDC recommends off-label use, that is considered a standard of care and supports a clinician’s professional decision to follow that recommendation. Depending upon an individual state’s scope-of-practice regulations, pharmacists may or may not be able to independently administer vaccinations under off-label conditions without a prescription or a standing order signed by a prescribing healthcare professional.

FDA labeling limits use in age-eligible people younger than age 65 to those with at least one high-risk underlying condition. Vaccination without such a condition is off-label, although the range of underlying conditions that increase the risk of severe disease is extremely broad. Recommended multidose schedules, including the second seasonal dose for adults age 65 years and older, are also off-label.